Description

MFG # N/A

UPC # 745749015365

VSL#3® JUNIOR is a probiotic medical food for children ages 2 to 12‚ for the dietary management of Irritable Bowel Syndrome and Ulcerative Colitis. VSL#3 JUNIOR consists of 8 strains of live freeze-dried lactic acid bacteria. Each packet contains 225 billion live probiotic bacteria and is supplied in a box containing 30 packets. (Watermelon flavor).

Medical Food:

As a medical food‚ VSL#3® is specially formulated and processed to providea precise mixture of certain bacterial species with potential synergistic relationships.

The importance of the gastrointestinal microflora in the normal functioning of the human gastrointestinal tract is well recognized. Several studies demonstrate that patients with IBS‚ UC‚ or an ileal pouch may have decreased luminal concentrations of lactobacilli and bifidobacteria compared with healthy individuals. Patients with IBS‚ UC‚ or an ileal pouch may benefit from consuming high levels of probiotic bacteria so as to maintain the appropriate quantity and balance of beneficial microflora in their gastrointestinal tract. This is particularly important for these patients in view of their frequent and often long-term antibiotic treatment and recent evidence implicating harmful intestinal bacteria in inflammatory bowel diseases. Hence‚ IBS‚ UC‚ and ileal pouch patients may have a distinct nutritional requirement that differs from normal individuals. Daily consumption of high levels of probiotic bacteria is needed to maintain adequate and balanced colonization in the gastrointestinal tract‚ and this cannot be achieved simply by modification of the normal diet.

VSL#3® is intended for use only by IBS‚ UC‚ or ileal pouch patients under the care of a physician.

Safety:

Probiotics have generally been associated with a long history of safe use. In fact‚ many probiotic species are integral to the production of fermented foods and have been consumed safely as part of these foods for millennia. Furthermore‚many bifidobacteria and lactobacilli species are normal‚ nonpathogenic inhabitants of the human gastrointestinal tract‚ oral cavity‚ skin‚ and vagina. While‚ theoretically‚ probiotic species could act as opportunistic pathogens‚ epidemiological surveillance data indicate that the risk of infection from consumption of lactobacilli is negligible. In the available literature‚ documented cases of infection attributable to probiotic treatment are rare and limited to case reports. These case reports are primarily associated with patients having compromised immune systems or other major health problems. Each strain of probiotic bacteria in VSL#3® is non pathogenic and non toxigenic.

Studies of VSL#3® have been conducted in several animal models of colitis and inflammatory liver disease. In experimental animal models of colitis‚ there are serious derangements in epithelial permeability and barrier function‚ causing the animals to be particularly vulnerable to bacterial translocation and inflammatory immune responses. Collectively‚ these studies demonstrate that VSL#3® may normalize gut permeability and barrier function and that it is associated with beneficial anti-inflammatory and immunomodulatory properties. The probiotics contained within VSL#3® do not translocate from the gut lumen or act opportunistically when ingested by animals suffering from colitis.

Clinical Experience:

VSL#3 JUNIOR has been the subject of extensive clinical research in the dietary management of IBS and UC.

In one IBS study‚ the consumption of VSL#3 was significantly superior to placebo (p <0.05 ) in the primary endpoint‚ the subjective assessment of relief of symptoms; as well as in a 3 of 4 secondary endpoints: abdominal pain/discomfort (p <0.05)‚ abdominal bloating /gassiness (p <0.05)‚ and family assessment of life disruption (p <0.01). No significant difference was found (p <0.06) in the stool pattern. No untoward adverse effect was recorded in any of the patients.

Published studies have suggested that daily ingestion of VL #3 Junior can aid in the dietary management of UC. The first study looked at the induction and maintenance of remission in children aged between 2 and 16‚ with ulcerative colitis. All 29 patients responded the inflammatory bowel disease (IBD) induction therapy. Remission was achieved in 13 children (92.8%) treated with VSL #3 and IBD therapy and in 4 children (36.4%) treated with placebo and IBD therapy (P<0.001). Overall‚ 3 of 14 (21.4%) children treated with VSL #3 and IBD therapy and 11 of 15 (73.3%) children treated with placebo and IBD therapy relapsed within 1 year of follow-up (P=0.014; RR=0.32; CI=0.025-0.773; NNT=2). Of the relapsed children‚ all 3 children treated with VSL #3 and 6 of 11 (54.5%) children treated with placebo relapsed within 6 months of diagnosis. At 6 months‚ 12 months‚ or a time of relapse‚ endoscopic and histological scores were significantly lower in the VSL #3 group than in the placebo group (p<0.05). There were no biochemical or clinical adverse events related to VL #3.

In the second study‚ 13 of 18 children completed 8 weeks of VSL #3 treatment and 5 patients were withdrawn due to lack of improvement. Remission (defined as SCCAI ≤ 3) was achieved in 56% of children (n=10); response (decrease in SCCAI ≤ 2‚ but final score ≤ 5) in 6% (n=1); and no change or worsening in 39% (n=7). Post- VSL #3 treatments demonstrated a bacterial taxonomy change in rectal biopsy. The VSL #3 was well tolerated in clinical trials and no biochemical and clinical adverse effects attributed to VL #3 were identified.

These statements have not been evaluated by the Food and Drug Administration (FDA). These products are not meant to diagnose‚ treat or cure any disease or medical condition. Please consult your doctor before starting any exercise or nutritional supplement program or before using these or any product during pregnancy or if you have a serious medical condition.

Some dairy ingredients are used in the culture medium but are removed during manufacturing. There might be trace amounts present at very low levels. For this reason VSL#3® is not defined as a dairy-free product but as a non- dairy product.

Gluten Free.

Kosher and Halal certified.

Dosage

Consume 1-4 packets (225 billion to 900 billion bacteria) daily or as directed by your physician. VSL #3 JUNIOR can be mixed into cold drinks such as water and juice or foods like applesauce or ice-cream and consumed. Adjustment of the intestinal flora can take a few days or weeks; it may take up to one month for the colonization of the gut to become optimally stable.

Dietary Management of IBS:- Less than 2 years 1/2 packet per day (open & add to soft food or beverages).- 2-5 years: 1/2 to 1 packet per day (open & add to soft food or beverages).- 6 -11 years: 1-2 packets per day.-12-17 years: 1-4 packets per day.

For children‚ the amount consumed per day varied by age‚weight and clinical study.

Precautions

Please keep this product out of reach of children. Pregnant or lactating women should consult with a physician or healthcare professional before using this or any other medical food product.

Drug Interactions: Avoid taking with antibiotics. Some antibiotics may inactivate certain strains of bacterium in VSL#3®.

Side Effects: Mild abdominal bloating has been reported in the first few days of consuming VSL#3®.

VSL #3 JUNIOR should be refrigerated (36-46° For 2-8°C). If stored under refrigeration‚ the product is guaranteed through“Best if used by” date. VSL #3 JUNIOR can be stored at room temperature for up to two weeks without adversely affecting potency.

If you have any general questions regarding orders or our policies and programs, please contact our Customer Happiness Team @ 1.800.383.6008

If you are pregnant, nursing, taking any medications or have any medical condition, consult your doctor before use. Your healthcare professional is the best source for guidance before beginning an exercise or nutritional supplement program.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.